Report on NIH Collaborations with Other HHS Agencies for Fiscal Year 2013

This annual report captures the extent and nature of activities undertaken by the National Institutes of Health (NIH) in collaboration with other agencies and divisions of the Department of Health and Human Services (HHS). As is often attributed to the philosopher and physician Aristotle (circa 300 B.C.), the whole is greater than the sum of its parts. For an organization as complex as HHS, which has many operating divisions and staff divisions, synergy between the different components of the Department is vital to the success of the whole. Recognizing this, Congress added section 403A(a) of the Public Health Service Act, 42 U.S.C. § 283a(a), Annual Reporting to Increase Interagency Collaboration and Coordination, via Section 104 of the National Institutes of Health Reform Act of 2006. This law mandates that the NIH Director provide to the Secretary of HHS an annual report on NIH’s collaborations with other HHS agencies. This, our seventh report to the Secretary, covers fiscal year 2013.

Background

The HHS mission is to provide essential human services and to protect the health of all Americans by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. As outlined in the HHS Strategic Plan, the Department sets forth four strategic goals to achieve this mission: 1) Strengthen Health Care; 2) Advance Scientific Knowledge and Innovation; 3) Advance the Health, Safety, and Well-Being of the American People; and 4) Ensure Efficiency, Transparency, Accountability, and Effectiveness of HHS Programs. Eleven operating divisions, including eight agencies in the United States Public Health Service and three human service agencies, administer HHS’s multifaceted programs. In addition, staff divisions provide leadership, direction, and policy guidance to the Department. Each HHS operating and staff division is an essential part of the larger public health ecosystem, fulfilling a unique role, from providing access to quality health care for all Americans, to reducing illness and disease and extending healthy life, to protecting our population from known and unknown public health threats, to maximizing the impact of the social service safety net. With more than 300 programs across the Department, the ultimate success of all components of the HHS public health ecosystem is interrelated – HHS agencies can achieve more together than by working in isolation. Interagency collaborations enable HHS agencies to capitalize on the strengths of individual mission areas to enhance the public health impact of the Department’s diverse programmatic activities – such cross agency synergism is necessary to accelerating progress in medicine and public health programs.

Since its origins in 1887 as the Marine Hospital Service, the NIH has been charged with improving health through research. As the largest research arm of HHS, the NIH’s mission is “to seek fundamental knowledge about the nature and behaviour of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.” The NIH’s collaborative efforts with other HHS agencies are vital to transforming fundamental scientific knowledge into useful applications that reach all Americans, such as disease treatments, preventive interventions, protective health policies and regulations, and public health campaigns. Information gathered by other HHS agencies on public health needs, in turn, informs the policies and priorities of NIH-funded research.

The NIH and other HHS operating and staff divisions collaborated on 572 activities in FY 2013. These numerous examples of cross-agency collaboration demonstrate the broad spectrum of health efforts that the NIH contributes to in partnership with the rest of the Department and are organized into six themes in this report:

Collaboration examples from each thematic area are included in Figure 1 (below) and described in the “FY 2013 Collaboration Highlights” section to follow.

Figure 1: Advancing the Public’s Health: Thematic Areas of NIH’s Collaborations with Other Agencies of the Department of Health and Human Services

FY 2013 Collaborative Activities by the Numbers

In FY 2013, the NIH collaborated with other HHS operating and staff divisions on 572 activities – 405 activities that did not require NIH funding and 167 activities funded with contributions from the NIH totalling $332,887,953.2 The Complete List of Activities Table provides a comprehensive list of all reported activities. The full details for each activity, including a brief description, the year the collaboration originated, FY 2013 funding, and participating HHS agencies as well as NIH Institutes, Centers, and Offices, can be viewed by clicking on the icon next to the “Details” column of each activity.

Each collaboration has been designated a category based on the nature of the activity – Chart 1 illustrates how the activities break down across the following categories: Committee, Work Group, or Advisory Group (256 activities); Research Initiative (144); Resource Development, e.g., developing databases, disease registries, and information clearinghouses (62); Meeting/Workshop (40); Health Survey (29); Public Education Campaign (22); Training Initiative (10); or Other (9). Half of the collaborations involving funding from the NIH were research initiatives (88 funded collaborative research initiatives for a total of $219 million). For the 405 collaborations that did not involve NIH funding, many relied on the NIH’s intellectual input, most commonly in the form of committees, work groups, and advisory groups (242 activities) and resource development (41 activities).

Chart 2 displays the number of collaborative activities that the NIH engaged in with each HHS operating or staff division, and Chart 3 plots the NIH’s funding contributions for those shared activities, again broken down by HHS division.3 As Chart 2 and Chart 3 illustrate, the majority of the NIH’s collaborations were with the CDC (357 activities totaling $169,770,946), FDA (244 activities totaling $119,443,381), and the HHS Office of the Secretary (OS) (164 activities totaling $24,984,955). Given the complementary missions of the CDC, FDA, and NIH, the three agencies often work closely together to build on each other’s respective strengths and achieve shared objectives. While the NIH conducts and funds basic and applied biomedical and behavioral research, the CDC engages in health promotion, prevention of disease, injury, and disability, and preparedness for new health threats, and the FDA ensures the safety of drugs, medical devices, and many other products that stem from biomedical research. There is also substantial cross-talk between the NIH and the OS, especially in the coordination of multi-agency initiatives, committees, and working groups.

FY 2013 Collaboration Highlights by Thematic Area

The following summary illustrates how the NIH works with our sister HHS agencies to help improve the health and well-being of the American public. Introduced in Figure 1 (above), examples of specific collaborations in each of the six highlighted themes are described in greater detail in this section. Ultimately, these diverse collaborative efforts feed into the public health ecosystem, helping to foster a healthier country and healthier world.

Theme 1: Assessing the Public’s Health

Cross-agency cooperation plays a pivotal role in defining the scope of public health issues, enabling better tracking of disease and disability. The NIH partners with other HHS agencies to collect and use data on disease prevalence as well as to understand the factors that contribute to wellness and illness within various parts of the population. Through such surveillance efforts, the Department can pinpoint current and emerging public health needs, and the NIH can refine research priorities. These intra-Departmental partnerships encompass efforts to examine disease prevalence and risk factors across a range of issues, such as cancer, kidney disease, and adolescent health behaviours. Important collaborations also address the needs of specific groups, including American Indian/Alaska Natives and the aging U.S. population. In this section, several health surveillance efforts and national surveys are highlighted.

HHS agencies collaborate on a variety of large-scale efforts to broadly measure population health and disease. The National Health Interview Survey (NHIS) (coordinated by the National Center for Health Statistics (NCHS) within the CDC) has collected data on the nation’s health since 1957 through personal household interviews. The NIH provides funding for the survey and several of the NIH Institutes sponsor special supplements or help design questions for the survey, and the results provide data to track health status, health care access, and progress toward achieving national health objectives. In a similar collaborative effort, the NIH also helps support the CDC’s National Health and Nutrition Examination Survey (NHANES). NHANES is a large program of studies designed to assess the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations to address a number of health conditions, as well as nutritional status for adults and children.

There are a number intra-Departmental surveillance efforts focusing on specific diseases and health challenges, such as recent efforts aimed at understanding and lessening the harmful effects of tobacco use. In 2013, as part of the CDC’s larger NHANES study, the NIH began a new research initiative to investigate environmental tobacco smoke exposure and mortality among nonsmokers. Another related example is the Population Assessment of Tobacco and Health (PATH) Study, a large-scale FDA-NIH collaboration to conduct a national longitudinal cohort study examining tobacco use and how it affects the health of Americans. The PATH study will follow an estimated 59,000 U.S. household residents ages 12 years and older for at least three years. By measuring and accurately reporting on the social, behavioral, and health effects associated with tobacco-product use, the PATH Study will provide an empirical evidence base to help inform the FDA’s tobacco regulations.

The NIH and the CDC also partner on surveillance efforts related to sudden death in the young (SDY). Inconsistent practices in investigation and reporting of SDY and sudden unexpected infant death (SUID) have hampered the ability to monitor national trends, ascertain risk factors, and design and evaluate programs to prevent these deaths. In 2013, the NIH and the CDC launched a new registry to track cases of sudden death in the young (up to age 24), including sudden cardiac death and sudden unexpected death in epilepsy (SUDEP). The registry is an expansion of the CDC's Sudden Unexpected Infant Death Case Registry, which previously tracked sudden unexpected deaths in children up to age one. Prior to the development of the Sudden Death in the Young Registry, such cases were not routinely or systematically reported. This new resource will help researchers define the scope of the problem and set future research priorities, as well as identify children at risk and test prevention strategies. The NIH's National Heart, Lung, and Blood Institute (NHLBI) will analyze data related to sudden cardiac death while the National Institute on Neurological Disorders and Stroke (NINDS) will participate in the registry by reviewing data on SUDEP. The Sudden Death in the Young Registry is jointly funded by the CDC, NHLBI, and NINDS.

Examining human interaction with environmental factors is an area of increasing importance in public health research. The Agricultural Health Study, sponsored by multiple NIH Institutes, the Environmental Protection Agency (EPA), and the National Institute for Occupational Safety and Health (NIOSH) of the CDC, is investigating the effects of environmental, occupational, dietary, and genetic factors on the health of agricultural workers. Focusing on individuals who are private or commercial pesticide applicators and their spouses, the study has enrolled approximately 90,000 participants in Iowa and North Carolina. In addition to the long-term effects on cancer incidence and mortality, ongoing studies are examining lung health, susceptibility to methicillin-resistant staphylococcus aureus (MRSA), and biomarkers of exposure and adverse effects in agriculture. Overall, the study will provide information that these workers can use in making decisions about their health and the health of their families, as well as inform the population about the effects of exposure to certain environmental factors.

Predicting the spread of infectious diseases is another important aspect of public health surveillance. The NIH and the CDC are working together on the Models of Infectious Disease Agent Study (MIDAS), a collaboration of research and informatics groups that are developing computational models of the interactions between infectious agents and their hosts, disease spread, prediction systems, and response strategies. These computational models should improve the public health workforce’s ability to understand and respond to outbreaks of infectious diseases.

Theme 2: Improving Diagnosis and Treatment through Research

In striving to provide the best options in medical care and health practice, the NIH works across the Department to support the science needed to develop new ways to diagnose and treat the diseases and disorders that cause the greatest burdens to society. The primary goal of NIH translational and clinical research is to improve public health interventions to provide the best available care for those who need it. Cooperative efforts with other HHS agencies, such as those described in this section, help to ensure that the wealth of information gleaned from research activities can be disseminated and implemented throughout the Department and in the community.

The Best Pharmaceuticals for Children Act (enacted in 2002, reauthorized in 2007, and made permanent by The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)) directs the Secretary of HHS, acting through the Director of the NIH, to establish a program for pediatric drug development. The goal of the Best Pharmaceuticals for Children Act (BPCA) Program is to improve pediatric therapeutics through preclinical and clinical drug trials that lead to drug labeling changes by the FDA. The NIH prioritizes drugs and therapeutics in need of study, sponsors the necessary pediatric clinical trials, and submits data to the FDA for labeling change. More than 20 NIH Institutes provide funding for these studies, and the NIH and the FDA work collaboratively on study design teams. Clinical trials in the BPCA Program are being designed and conducted through the BPCA Pediatric Trials Network. To date, four drug labels have been changed as a result of the BPCA, and several other data packages have been submitted for the FDA’s consideration.

The NIH also works closely with the HRSA’s Maternal and Child Health Research Program to translate basic knowledge into practical applications that enhance the health and wellbeing of mothers, children, and families, as well as testing whether existing interventions are effective and safe in real-world settings. For example, the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) partners with the HRSA to fund the Confederated Pediatric Electronic Health Record Research Network (CPEHRRN). This research network conducts cutting-edge studies using electronic health records (EHRs) from approximately 800,000 U.S. children. The five-year study will use EHR-based practice systems and other electronic data to conduct observational comparative effectiveness research (CER) on the use of and long-term side effects of pharmaceutical treatments in children, including selected psychotropic medications and the most commonly prescribed asthma medications. Results from this study will help refine our understanding of the safety and effectiveness of some of the most commonly used medications in pediatric populations.

The Administration for Community Living (ACL) and the NIH’s National Institute on Aging (NIA) have partnered in recent years to address the complementary goals of the two agencies to improve the health and well-being of older Americans. Through a joint research initiative, Translational Research to Help Older Adults Maintain their Health and Independence in the Community, the NIA and the ACL support translational research that moves evidence-based research findings towards the development of new interventions, programs, policies, practices, and tools that can be used by community-based organizations to help elderly individuals remain healthy and independent. Further, a working group of NIH and ACL staff meet regularly to identify evidence-based interventions that are ready for dissemination and implementation in community programs and to work more collaboratively on their translation into the community. Areas of interest identified to date are diverse and include family caregiving, exercise and physical activity, nutrition, elder mistreatment and abuse, falls, driving, sleep, medication management, depression and mental health, living with long-term disability, stroke, and Alzheimer’s disease. These collaborative efforts include devising strategies to evaluate the success of these dissemination and implementation efforts.

Accelerating the dissemination of research-based treatment into clinical practice is also the core mission of a partnership between the NIH’s National Institute on Drug Abuse (NIDA) and the SAMHSA, known as the Blending Initiative. The NIDA and the SAMHSA joined together to create the Blending Initiative in 2001 to reduce the gap that exists between the publication of research results on drug abuse and the impact on treatment delivery. This initiative draws on input from clinicians, scientists, and experienced trainers to catalyze the creation of user-friendly treatment tools and products and to facilitate the adoption of research-based interventions into front-line drug abuse treatment settings. Through this initiative, the NIDA and SAMHSA’s Addiction Technology Transfer Centers (ATTCs) disseminate treatment and training products based on results from studies conducted by the NIH, including those in the National Drug Abuse Clinical Trials Network (CTN).

The Foundation for the NIH Biomarkers Consortium is a public-private biomedical research partnership managed by the Foundation for the National Institutes of Health that endeavors to discover, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics. Biomarkers are objectively measurable indicators of normal and abnormal biological states. Body temperature, for example, is considered an effective biomarker for fever, and blood pressure can predict the risk of stroke and coronary heart disease; however, for many diseases, clinicians lack reliable ways to identify disease and assess response to treatment. With participation by the NIH, FDA, and CMS—as well as by private sector members (the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO))—the Biomarkers Consortium is helping create a new era of personalized medicine, with more highly predictive markers that have an impact during a patient’s illness or lifespan. The goal is to combine the forces of the public and private sectors to accelerate the development of biomarker-based technologies, medicines, and therapies for the prevention, early detection, diagnosis, and treatment of disease. As of April 2014, the Consortium has launched ten projects in areas as diverse as Alzheimer’s disease, cardiovascular disease, diabetes, and breast cancer. A number of other promising projects are also moving forward for implementation.

Theme 3: Preventing Disease and Disability

Preventing disease and disability before it starts is critical to helping people live longer, healthier lives. Poor diet, physical inactivity, tobacco use, and alcohol misuse all have been shown to have terrible health consequences for Americans. Minimizing these and other risk factors can result in major public health gains. Aligning and coordinating efforts across HHS is central to the success of national prevention strategies. The NIH works to expand the evidence-base for prevention strategies and partners with other HHS agencies on more than 100 prevention activities, engaging partners across disciplines, sectors, and institutions to change the way communities conceptualize and solve problems, enhance implementation of innovative strategies, and improve individual and community well-being. Examples of interagency prevention efforts include those aimed at reducing heart attacks and strokes, asthma, smoking, underage drinking, and a range of other harmful health effects and behaviors, including the following highlighted collaborations.

HHS has a long history of HIV/AIDS work within the United States and at the global level. For example, many HHS agencies contribute to the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), a U.S. Government initiative led by the U.S. Global AIDS Coordinator to help save the lives of those suffering from HIV/AIDS around the world. PEPFAR is the cornerstone and largest component of the U.S. President’s Global Health Initiative. Structures and systems have been established at every level of the U.S. Government working in international HIV/AIDS to ensure a unified strategic approach to combating the epidemic abroad. HHS agencies work together to assist in developing research and evaluation priorities for PEPFAR, to conduct HIV/AIDS research through the CDC, FDA, HRSA, NIH, and SAMHSA, and to help implement effective prevention, treatment, and care programs in developing countries. The NIH provides technical expertise on issues related to safety and efficacy of interventions implemented in PEPFAR programs and facilitates evaluation of PEPFAR programs through NIH-funded grants. Recent NIH research initiatives under PEPFAR have focused on testing treatment as prevention at the population level in Africa, including the prevention of mother-to-child HIV transmission.

Approximately seven million American children under the age of 17 have asthma, and a disproportionate number of those children are minorities living in poverty.4 As members of the President's Task Force on Environmental Health Risks and Safety Risks to Children, the NIH, ACF, AHRQ, CDC, CMS, FDA, HRSA, IHS, and OS all contributed to the development of the Coordinated Federal Action Plan to Reduce Racial and Ethnic Asthma Disparities (Action Plan) released in May 2012. The goal of the Action Plan is to reduce the burden caused by asthma, especially among children—in particular, minority children and children with family incomes below the poverty level. The Action Plan promotes collaboration and coordination among federal agencies to leverage existing resources to address the multi-leveled causes of asthma disparities. The plan was developed by a working group of the President's Task Force on Environmental Health Risks and Safety Risks to Children, the Asthma Disparities Working Group, which was co-chaired by HHS, the EPA, and the Department of Housing and Urban Development (HUD).

Another major public health goal is to stem the rising rates of diabetes, the seventh leading cause of death in the United States.5 Diabetes is a debilitating disease that lowers average life expectancy by up to 15 years and affects an estimated 25.8 million people in the United States—or 8.3 percent of the total population—including an estimated seven million people who remain undiagnosed.6 Type 2 diabetes, which accounts for more than 90 percent of diabetes among adults, often can be averted or delayed by lifestyle factors.7 The NIH, in collaboration with the CDC and the IHS, continues to support the Diabetes Prevention Program, started in 1994. This long-term outcomes study has shown that diet and exercise or the diabetes medication, metformin, can delay the onset of diabetes by ten years.

One major contributor to increasing diabetes rates is childhood obesity—more than 33 percent of children and adolescents in the United States are overweight or obese.8 Because most obese children grow up to be overweight or obese adults, preventing obesity during childhood is critical. To advance and accelerate progress in addressing the nation’s childhood obesity epidemic, the NIH and the CDC along with the U.S. Department of Agriculture (USDA) and private foundation partner, the Robert Wood Johnson Foundation (RWJF), formed the National Collaborative on Childhood Obesity Research (NCCOR). NCCOR’s mission is to improve the efficiency, effectiveness, and application of childhood obesity research in an effort to halt—and reverse—childhood obesity through enhanced coordination and collaboration. In building on each other’s strengths, the CDC, NIH, RWJF, and USDA are advancing the field through complementary and joint projects, such as a study to evaluate community programs to reduce childhood obesity. This public-private collaboration spurs action, provides strategic direction, and is building a strong foundation of research to guide the nation’s efforts to prevent and reduce childhood obesity.

Another serious and preventable public health problem is suicide. The CDC reports that more than 36,000 Americans die by suicide each year.9 This translates to roughly four suicides per hour, greater than the number of homicide- or motor vehicle-related fatalities. Through the National Action Alliance for Suicide Prevention (Action Alliance), the federal government and private groups are bringing their collective strengths to bear on reducing suicide and suicidal behaviors. Involving numerous public members and representatives from the Departments of Defense, Education, Justice, Interior, Veterans Affairs, and HHS (including the ACL, CDC, HRSA, IHS, SAMHSA, NIH, and the Assistant Secretary for Health), the Action Alliance formed an expert group, the Research Prioritization Task Force (RPTF), to revise and update a national suicide prevention strategy. In 2012, the RPTF released the 2012 National Strategy for Suicide Prevention: Goals and Objectives for Action. More recently in FY 2013, the RPTF worked to refine specific research priorities for suicide prevention, which culminated in the release of A Prioritized Research Agenda for Suicide Prevention: An Action Plan to Save Lives in February 2014. The plan outlines the research areas that show the most promise in helping to reduce the rates of suicide attempts and deaths in the next five-ten years, if optimally implemented. The NIH, through its contributions to the RPTF, seeks to identify and fund research with the potential to prevent suicide attempts and deaths.

Theme 4: Providing Evidence-Based Health Information

As illustrated in the preceding section, the biomedical and behavioural research that the NIH funds forms much of the evidence base for understanding health risks. However, to have a tangible impact on population health, this information must be effectively and broadly communicated to the American public in order to empower individuals to make informed personal decisions about their health. To this end, the NIH works with other HHS agencies on numerous large-scale health promotion campaigns and information portals. Examples include informational websites dedicated to diabetes, kidney disease, osteoporosis, and bullying. A few other notable public health campaigns and information portals are highlighted below.

Every five years, HHS and the USDA update the Dietary Guidelines for Americans, which are recommendations for individuals ages two years and over that provide the basis for federal food and nutrition policy and education initiatives. The Dietary Guidelines encourage Americans to focus on eating a healthful diet that helps achieve and maintain a healthy weight, promotes health, and prevents disease. The recommendations are based on a rigorous review of relevant scientific evidence by the Dietary Guidelines Advisory Committee (DGAC), consisting of nationally recognized experts in the field of nutrition and chronic disease prevention. HHS’s Office of Disease Prevention and Health Promotion has the administrative leadership for the 2015 edition and is strongly supported by the USDA’s Center for Nutrition Policy and Promotion in committee and process management, as well as with evidence analysis functions. In 2013, the NIH hosted the first meeting of the 2015 DGAC, and the NIH, CDC, and FDA are supporting the DGAC throughout the revision process for the 2015 edition of the Dietary Guidelines for Americans.

The Dietary Guidelines for Americans as well as other related research and public health efforts inform education initiatives such as We Can! (Ways to Enhance Children's Activity & Nutrition). We Can! is a national education program that targets eight- to 13-year-olds to encourage healthy eating, increased physical activity, and reduced time sitting in front of the screen (TV or computer). Partnering with the CDC and the HRSA, four NIH Institutes created science-based educational programs, support materials, training opportunities, and other resources for parents and caregivers. In 2013, the NIH held a conference for organizational leaders and partnered with HHS’s Center for Faith-Based and Neighborhood Partnerships to promote the We Can! health education campaign. NIH staff co-led a series of training webinars, hosted by the Partnership Center, to train hundreds of community leaders across the country in implementing We Can! programs.

At the other end of the lifespan, Go4Life, an exercise and physical activity campaign led by the NIH’s National Institute on Aging in partnership with the ACL, AHRQ, CDC, and OS, is designed to help individuals fit exercise and physical activity into their daily lives. Motivating older adults to become physically active for the first time, return to exercise after a break in their routines, or build more exercise and physical activity into weekly routines are the essential elements of Go4Life. Go4Life offers exercises, motivational tips, and free resources to help individuals get ready, start exercising, and keep going. The Go4Life campaign includes evidence-based exercise guides in English and Spanish, an exercise video, an interactive website, and national outreach activities.

Sponsored by the CDC, HRSA, and the NIH’s Office of AIDS Research (OAR), National Institute of Allergy and Infectious Diseases (NIAID), and National Library of Medicine (NLM), AIDSinfo offers access to the latest, federally approved HIV/AIDS medical practice guidelines, HIV treatment and prevention clinical trials, and other research information for health care providers, researchers, people affected by HIV/AIDS, and the general public. These English- and Spanish-language websites (InfoSIDA) assist in the dissemination of the Public Health Service Treatment Guidelines, as well as information about both approved and investigational HIV/AIDS treatments. The site also provides mobile resources and tools, such as the HIV/AIDS Glossary App, an on-the-go guide to the complex terminology of HIV/AIDS with easy-to-understand definitions for more than 700 HIV/AIDS-related terms in English and Spanish, as well as fact sheets that serve as a source of readily available evidence-based information.

ChildStats.gov represents another cross-Agency web resource providing high-quality, up-to-date information on the health status of children and families. Leading this effort, the Federal Interagency Forum on Child and Family Statistics (Forum) is a collection of 22 federal agencies involved in research and activities related to children and families, including the HHS operating divisions of the ACF, AHRQ, CDC, HRSA, NIH, and SAMHSA. The mission of the Forum is to foster coordination and collaboration and to enhance and improve consistency in the collection and reporting of federal data on children and families. In 2013, the Forum published a new annual report, America's Children: Key National Indicators of Well-Being, 2013, which contains national indicators of child well-being, including family and social environment, economic circumstances, health care, physical environment and safety, behavior, education, and health, and reports changes in these indicators over time. In addition to providing data in an easy-to-use, nontechnical format, the purpose of the report is to stimulate discussions among policymakers and the public, exchanges between data providers and policy communities, and improvements in federal data on children and families.

Theme 5: Keeping Americans Safe

Through research, regulation, and policy development, HHS agencies are committed to protecting the health and safety of all Americans. With its HHS and other federal partners, the NIH works to ensure that proper policies are in place to protect the public, including confirming that medical products are safe and effective, that emerging health and biosecurity threats can be identified and addressed swiftly, that appropriate biosafety protocols are in place to prevent laboratory accidents, and that scientific information is used in responsible ways.

Life sciences research has the recognized potential for many beneficial outcomes, such as improvements in health, increased quality of life, and strengthening the national economy. However, if misused, life sciences research also holds the potential for harm. This so-called dual use research of concern (DURC) poses increasingly complex biosecurity issues, both domestically and internationally. DURC is legitimate life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, to agricultural crops and other plants, to animals, to the environment, to materiel, or to national security. HHS—including the OS, CDC, FDA, and NIH—has been working actively with interagency partners toward the development of comprehensive federal policies for DURC oversight. In March 2012, a U.S. Government policy was issued, requiring federal funding agencies to review their research portfolios to identify those projects that constitute DURC and to ensure that appropriate risk mitigation measures have been implemented. The U.S. Government is finalizing a second policy that describes the responsibilities of research institutions in identifying DURC and implementing risk mitigation measures.

HHS must be poised to address emergency health risks, and several interagency collaborations aid this effort. Under the leadership of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), the NIH participates in the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), the coordinating body for federal agencies in charge of employing medical countermeasures to protect the civilian population from potential adverse health impacts from chemical, biological, nuclear, or radiological threats. Medical countermeasures are medicines, devices, or other medical interventions that can lessen the harmful effects of these threats. This preparedness effort includes representatives from the OS, NIH, FDA, and CDC, as well as the U.S. Departments of Defense, Veterans Affairs, Homeland Security, and Agriculture. Legislation passed in 2013 enables HHS to develop a five-year budget plan on the medical countermeasures enterprise, which will aid strategic project coordination and communicate priorities to partners and stakeholders.

The NIH also collaborates across the Department to support research efforts in disaster preparedness, response, and recovery. Recognizing the value in conducting research during disasters to better inform planning for future incidents, the NIH developed the Disaster Research Response (DR2) Project. This project aims to create an environmental health disaster research system through platforms of ready-to-go research data collection tools and a network of specially trained research responders. Administered by the NIH, the project coordinates efforts of the ATSDR, CDC, FDA, and OS (i.e., the Office of the ASPR). Elements of the system include epidemiologic questionnaires and clinical protocols, specially trained disaster researchers, environmental health disaster research networks, a reach-back roster of subject matter experts, and a support infrastructure that can be activated and deployed during public health emergencies and declared disasters. This effort will provide invaluable lessons and platforms for advancing timely post-disaster research activities.

Another major area of concern for public health is the effects of chemical exposures from various sources including food, household cleaning products, and medicines throughout the lifespan. The Toxicology in the 21st Century (Tox21) program, a federal collaboration involving the NIH, FDA, and EPA, is aimed at developing better assessment methods to quickly and efficiently test whether certain chemical compounds have the potential to lead to adverse health effects. NIH-funded scientists are using a high-throughput screening robotic system to test chemical compounds in cellular and biochemical assays for their potential to disrupt biological pathways that may result in toxicity. The Tox21 program is co-funded and co-administered by the EPA’s National Center for Computational Toxicology and the National Toxicology Program (NTP), an interagency program supported by the NIH, FDA, and EPA. Together, the NIH and the EPA bring an enormous wealth of experience in animal and computational toxicology to the Tox21 collaboration and utilize the research results to develop cost-effective approaches for prioritizing the thousands of environmental chemicals that require toxicity testing. The FDA brings expertise and safety information on pharmaceutical drugs and food substances to the collaboration. As research data are generated, both the EPA and the FDA plan to apply the knowledge gained to the products they regulate.

The NIH also collaborates across the Department on issues of patient safety, helping to minimize the occurrence of adverse medical events. For example, the HHS Safety Reporting Portal (SRP) streamlines the process of reporting product safety issues to the FDA and the NIH. This portal represents one of the initiatives of the Federal Adverse Events Task Force, which includes representatives from the AHRQ, CDC, FDA, NIH, and HHS’s Office for Human Research Protections in the OS. The Safety Reporting Portal has established greater harmonization among federal agencies for the reporting of adverse events and product problems. Certain researchers, food manufacturers, and drug manufacturers are required by law to submit safety reports through the portal. Furthermore, the web-based system enables anyone with Internet access the ability to report a safety concern about a medical product, as well as about foods, cosmetics, animal feed, and veterinary products.

Theme 6: Broad, Multi-Purpose Coordination

Given the complexity of major public health challenges, there is often a need for formal cross-agency strategic planning to ensure that all of the agencies within the Department are working in concert toward larger health goals with multiple purposes. The five-year HHS Strategic Plan described above and the intergovernmental ten-year agenda for improving the nation’s health, Healthy People 2020, are prime examples of strategic planning endeavors that outline pathways to achieve broad, health-related objectives. Other important interagency strategic planning activities are focused on achieving better outcomes in specific health topics, such as diabetes, HIV/AIDS, tuberculosis, antimicrobial resistance, and health equity in underserved populations, among many others. The following interagency collaborations illustrate how the NIH works with other HHS agencies and often other federal departments to coordinate broad planning efforts.

In concert with the HHS Initiative on Multiple Chronic Conditions, the NIH partners across the Department to improve the health of individuals who have multiple chronic conditions (e.g., two or more long-term diseases, disorders, or disabilities). Recognizing the importance of multiple chronic conditions to patients, caregivers, and the health care system, the Assistant Secretary for Health convened an HHS-wide work group on Multiple Chronic Conditions (MCC) to identify options for improving the health of this population. In 2010, the work group, in conjunction with other stakeholders, developed the Multiple Chronic Conditions: A Strategic Framework. The Framework serves as a national-level roadmap for assisting HHS programs and public and private stakeholders to improve the health of individuals with multiple chronic conditions. In 2013, the NIH published MCC-focused funding opportunities to: 1) increase clinical, community, and patient-centered research involving patients with MCC; 2) foster the development of a common conceptual model to develop behavioral interventions to improve health outcomes in patients with MCC; and 3) enable demonstration projects across health care systems for efficient, large-scale pragmatic clinical trials focused on management of patients with MCC.

Members of the HHS Coordinating Committee on Women’s Health, composed of representatives from each of the agencies and offices within HHS, advise the Assistant Secretary for Health on current and planned activities across HHS that would safeguard and improve the physical and mental health of all women in the United States. The committee has identified the prevention and intervention of domestic/intimate partner violence (IPV) as a priority focus for cross-federal initiatives. In December 2013, HHS convened a research symposium at the NIH with the purpose of identifying research gaps in screening and counseling for IPV in primary health care settings and to shape priorities in the national research agenda moving forward. Ultimately, the Department’s goal is to promote effective strategies for health care practitioners for screening and counseling.

In addition to interagency coordination, interdepartmental coordinating efforts also work to achieve common goals more effectively, such as the federal government’s efforts to implement the National Alzheimer’s Project Act (NAPA). Signed into law in January 2011, NAPA established the Advisory Council on Alzheimer’s Research, Care, and Services to coordinate research and services across federal agencies, to accelerate the development of treatments for Alzheimer’s disease and related dementias, to improve early diagnosis and coordination of care, to reduce ethnic and racial disparities in rates of Alzheimer’s disease and related dementias, and to coordinate with international efforts to fight these conditions. In addition to the ten HHS agencies involved in this collaboration, the group further coordinates efforts across the government by partnering with the Department of Veterans Affairs (VA), the National Science Foundation (NSF), and the Department of Defense (DoD). In June 2013, the Advisory Council and the Secretary of HHS released the National Plan to Address Alzheimer’s Disease: 2013 Update, a follow-up to the initial plan released in 2012. The update reflects national progress towards accomplishing the goals set forth initially, as well as new and revised action steps.

The Interagency Autism Coordinating Committee (IACC) is another example of both interagency and interdepartmental collaboration in strategic planning and cooperation. This group coordinates all efforts within HHS concerning autism by developing an annual Strategic Plan for Autism Spectrum Disorder Research and advising the HHS Secretary on issues related to autism. Membership of the Committee includes the directors of five NIH Institutes, seven other HHS agencies (ACF, ACL, AHRQ, CMS, CDC, FDA, and HRSA), the Department of Education (DoEd), and the DoD, as well as a number of public stakeholders, to ensure that a variety of perspectives from within the autism community are considered in the Committee’s strategic planning and coordination efforts. The exchange of information between agencies and the public facilitated by the IACC has catalyzed several endeavors to benefit those with autism and their families. In addition to the Strategic Plan, the IACC, supported by NIH staff, also produces a portfolio analysis of data from both public and private funders to chart the current autism research investment landscape to inform implementation of the plan.

In response to the 2012 White House Executive Order, Improving Access to Mental Health Services for Veterans, Service Members, and Military Families, the NIH has worked closely with colleagues across HHS and with the DoD, DoEd, and VA to develop a National Research Action Plan on post-traumatic stress disorder and traumatic brain injury. The plan was released in 2013, and the NIH participates in a Post-traumatic Stress Disorder (PTSD)/Traumatic Brain Injury (TBI) Workgroup to plan and coordinate federal investments in research that will have an impact on treating these disorders. In addition, the NIH is co-leading the development of sophisticated data systems to provide new means for sharing research data that will be vital to leveraging research resources. To develop data sharing policies and strategies to improve TBI research, a federal interagency working group is informing the construction of a secure, centralized database for TBI research. Along with the NIH, the CDC, HRSA, SAMHSA, OS, DoD, DoEd, and VA developed the Federal Interagency Traumatic Brain Injury Research (FITBIR) Informatics System, which serves as a central repository for new data, links to current databases, and allows valid comparison of results across studies. The FITBIR Informatics System has the potential to facilitate collaboration between laboratories and to accelerate research progress on this major medical issue.

Conclusions

HHS accomplishes its mission to enhance the health and well-being of Americans through several hundred programs and initiatives that cover a wide spectrum of activities, serving the American public at every stage of life. America’s investment in the NIH provides the nation with a unique resource—a scientific agency devoted to the creation of a knowledge base needed to conquer the most devastating human diseases and disabilities. In order for this rich knowledge base to improve health, the Department, as well as the entire federal government and the private sector, must work in concert to cultivate ground-breaking research and ensure that scientific knowledge is translated into sound regulations and policies, health services and medical interventions, and information that all Americans can use to lead healthier lives.

The NIH appreciates the opportunity to report on its multifaceted collaborations within the Department of Health and Human Services. The policies, programs, and regulatory and service activities developed and carried out by HHS operating and staff divisions are some of the most effective means that the government can use to improve the health and well-being of its citizens. The collaborative activities detailed in this report illustrate how the NIH works across the Department to cultivate partnerships, leveraging the respective strengths of all HHS agencies to support the HHS mission and strengthen the public health ecosystem.

[1] The staff divisions of the Office of the HHS Secretary (OS) include: the Immediate Office of the Secretary (IOS), Assistant Secretary for Administration (ASA), Assistant Secretary for Financial Resources (ASFR), Assistant Secretary for Global Affairs (ASGA), Assistant Secretary for Health (ASH), Assistant Secretary for Legislation (ASL), Assistant Secretary for Planning and Evaluation (ASPE), Assistant Secretary for Preparedness and Response (ASPR), Assistant Secretary for Public Affairs (ASPA), Center for Faith-Based and Neighborhood Partnerships (CFBNP), Departmental Appeals Board (DAB), Office for Civil Rights (OCR), Office of the General Counsel (OGC), Office of Inspector General (OIG), Office of Intergovernmental and External Affairs (IEA), Office of Medicare Hearings and Appeals (OMHA), and the Office of the National Coordinator for Health Information Technology (ONC

[2] Funding levels are reported and verified by budget officers in the various Institutes, Centers, and Offices within the NIH Office of the Director. Funding levels in this report may not be consistent with those reported under the Estimates of Funding for Various Research, Condition, and Disease Categories (RCDC) at the NIH Office of Budget website at http://report.nih.gov/categorical_spending.aspx. The current RCDC process, implemented in 2008, uses sophisticated text data mining (categorizing and clustering using words and multi-word phrases) in conjunction with NIH-wide definitions used to match projects to categories. RCDC use of data mining improves consistency and eliminates the wide variability in defining the research categories reported. The definitions are a list of terms and concepts selected by NIH scientific experts to define a research category. The RCDC research category levels represent the NIH’s best estimates based on the category definitions.

[3] Individual collaborative activities can involve multiple HHS agencies. Therefore, the values displayed in Chart 2 and Chart 3 reflect duplicate counts and add up to more than the total reported sums.

[5] Centers for Disease Control and Prevention. National Diabetes Fact Sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011. Retrieved from http://www.diabetes.niddk.nih.gov/dm/pubs/statistics/.